Stability Quality Assurance Manager, SPM and SPA
AstraZeneca Södertälje / Kemiingenjörsjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos AstraZeneca Södertälje i Södertälje,
Huddinge,
Solna,
Mölndal eller i
hela Sverige Global Technical Services - Stability within Operations Quality, based in Sodertalje, Sweden is now looking for a Stability Quality Assurance Manager (SQAM), a Stability Program Manager (SPM) and a Stability Program Associate (SPA) Temporary roles until end June 2017.
The arena
Global Technical Services (GTS) is a Central Quality Operations group, responsible for the technical support of all established, small molecule products and major brands developed in AZ, including the responsibility for the management of the AZ global stability program and all the associated activities.
GTS-S is responsible for the Management of the commercial stability Program and Quality system which supports all AstraZeneca?s small molecule Drug Substances and Drug Products. GTS-S has prime accountability for proactive and focused support on all aspects of stability management for all global Operations sites and CMOs. The group has a technical, scientific and regulatory skill set.
The roles
Stability Quality assurance manager (SQAM)
The SQAM has responsibility for a Commercial product portfolio. The job holder is responsible for Stability Quality Assurance, in relation to all aspects of the global commercial stability management and will evaluate stability information to support license management for global commercial products.
Overall surveillance of data, global product stability profiles and issues arising from the global commercial stability program by evaluation and trending across all stability information:
Technical assessment of impact of; supply chain changes, process and packaging changes, and translation of these into appropriate programs of stability studies.
Assurance of the integrity of stability study reports intended for submission to regulatory agencies, including; selection of studies; scientific rational used in discussions/conclusions; compliance with the regulations of the health authorities that will receive the report.
Initiate/coordinate/participate in investigations
Stability QA support for Operations sites, e.g. stability contribution to APR/PQR, Temperature Excursions, Health Authority inspections, Stability technical support.
Commercial stability input to NPI projects and take over the stability QA responsibilities after handover from R&D.
Stability Program manager (SPM)
The SPM is responsible for ensuring by generation, provision and maintenance of the Global Commercial Stability Program.
Generation and maintenance of the Stability Master Plans and the supporting stability test protocol information
Ensure the global stability programme fulfils all regulatory requirements, and is optimized and effective.
Communication of the Stability Master Plans to the Stability QC Centres.
Translation of stability sections in CMC documentation and Commitments into the Stability Master Plan.
Assure the provision of accurate, submission ready stability data information that is in compliance with market specific Health Authority.
Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.
Maintenance and update of storage life records within S-Life.
Stability Program Associate (SPA)
The SPA is responsible for ensuring by generation, provision and maintenance of the Global Commercial Stability Program.
Collation, Review and approval of submission ready stability data
• ......................FOR FULL JOB DESCRIPTION AND TO APPLY, visit
www.astrazeneca.se/karriarVaraktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-06-08ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-06-30
Ange följande referens när du ansöker: GOT0000006V
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Västra Mälarhamnen 9
15185 Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 2893845
Observera att sista ansökningsdag har passerat.